Preliminary Evaluation of CASTLE Barrier Prototype UK

This study has been terminated.
(Inability of site to recruit/enroll target population)
Sponsor:
Information provided by (Responsible Party):
Hollister Incorporated
ClinicalTrials.gov Identifier:
NCT01530087
First received: February 7, 2012
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to provide preliminary assessment of the safety and performance of a novel barrier formulation (CASTLE) in a small population of subjects with irritated peristomal skin.


Condition Intervention
Peristomal Skin Irritation
Device: CASTLE barrier

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Peristomal Skin Irritation: A Preliminary Evaluation of the CASTLE Barrier Prototype for People With Intestinal Stomas

Further study details as provided by Hollister Incorporated:

Primary Outcome Measures:
  • Peristomal skin irritation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Security [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    wear time leakage barrier erosion


Enrollment: 3
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
subjects with ileostomy or colostomy Device: CASTLE barrier
Prototype barrier to be used in place of current two piece device

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample of referral population meeting eligibility criteria

Criteria

Inclusion Criteria:

  • at least 18 years of age
  • has colostomy or ileostomy
  • current uses two piece tape bordered barrier
  • has mild to moderate peristomal skin irritation
  • cares for their stoma independently in the community
  • at least 3 months post-operative
  • provides informed consent

Exclusion Criteria:

  • has fistula on or near stoma
  • has been involved in stoma care study in the last 30 days
  • is pregnant or lactating (determined by interview only)
  • has existing medical condition that would compromise their participation or follow-up
  • currently uses convex ostomy products, paste and/or rings
  • is allergic to test barrier components
  • is undergoing chemo- or radiotherapy that may affect the interpretation of the results
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530087

Locations
United Kingdom
York Teaching Hospital
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Hollister Incorporated
Investigators
Study Director: Richard Murahata, PhD Hollister Incorporated
  More Information

No publications provided

Responsible Party: Hollister Incorporated
ClinicalTrials.gov Identifier: NCT01530087     History of Changes
Other Study ID Numbers: 4518-O, CIV-GB-11-07-001241
Study First Received: February 7, 2012
Last Updated: September 4, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Hollister Incorporated:
colostomy
ileostomy
peristomal skin condition
two piece barrier

ClinicalTrials.gov processed this record on August 21, 2014